Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088959
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/02/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/22/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/04/1992 SUPPL-10 Labeling

Label is not available on this site.

12/22/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/05/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/02/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/17/1989 SUPPL-6 Labeling

Label is not available on this site.

02/26/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/26/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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